Grasp-Release Assessment of a Networked Neuroprosthesis Device

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT05863754
Status
Recruiting
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Conditions

  • Spinal Cord Injuries
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury at C5-C7 Level

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Networked Neuroprosthesis Device — DEVICE
    The Networked Neuroprosthesis Device is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals.

Study Details

The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI.

Key Dates

Start date
Jan 23, 2022
Status verified
Aug 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Intervention - implant neuroprosthesis
    Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.

Primary Outcome Measure

Change in Grasp-Release Test [ Time Frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109
Anne Bryden, Ph.D, OTR/L
[email protected]
216-957-3594

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By research site
MetroHealth Medical Center· Cleveland, OH

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